FAQ - Conducting Research: Background Information

How do I know if my proposed research activities require HRRC review? The types of activities that require HRRC review are described in a guidance issued by the Office of Human Research Protections (OHRP) located within the Department of Health and Human Services (DHHS). OHRP guidance - engaged in research It describes cases when an institution becomes engaged in research through the actions of its students, employees, or affiliates.

Who approves research activities at GVSU?
The University, through its departmental administrative structures, approves all research at GVSU. This includes bench science research, and research on human and animal subjects. For research involving human subjects, the University also requires approval from its Institutional Review Board (IRB), known at GVSU as the Human Research Review Committee (HRRC). The HRRC approval of research activities certifies that proposed research activities are in compliance with Federal Regulations, University policies and procedures, and ethics standards pertaining to the protection of the rights, interests and welfare of human subjects' research.

What is a Federal Wide Assurance?

GVSU has assured the federal government that all research conducted under GVSU authority will comply with federal regulations as specified under the Code of Federal Regulations the DHHS 45 CFR 46 and FDA 21 CFR 50 and 56 subparts for the protection of human subjects. This assurance pertains to all requirements and procedures specified by all eleven signatory federal agencies and departments. That is why it is called a Federal Wide Assurance (FWA).

Who must have an FWA?

Any individual or entity engaged in federally sponsored research involving human subjects must have an FWA or have the research activity reviewed and approved by an Institutional Review Board (IRB) at an institution that holds an FWA. Researchers are not allowed to receive research grant funds directly from the federal government. The researcher's employing institution receives the money and uses it to pay the costs of the research, including a percentage of the researcher's salary. Every institution adds a percentage on top of the actual research costs for use of its institutional resources to support research activities, called indirect costs (ICs). For example, if a researcher's project costs (including salary) total $100,000, and the institution's indirect costs are 35%, then the grant is written for $135,000. The federal government limits the ICs percentage that it will pay, but state, private, and other granting agencies and foundations set different limits.

The principle focus of the Assurance is to hold GVSU accountable for (1) prohibiting any unauthorized research, and (2) ascertaining that all approved research activities are compliant with federal regulations planned such that risks to participants are minimized, there is a reasonable ratio of risk to direct or indirect benefit, privacy is protected, data is secured, participation is informed and voluntary, consent is ethically and legally valid. The FWA document basically makes three separate assurances:

1. All GVSU researchers (faculty, staff and students) are sufficiently knowledgeable abut the relevant federal regulations to protect research participants;

2. Researchers will always comply with the regulations unless an alteration or waiver of certain subparts has been documented by the HRRC;

3. If a researcher violates the regulations GVSU will report it to the appropriate federal officials or offices, take corrective internal action, and institute internal review and other preventive measures to prevent any recurrence.

If an institution does not want federal funding for research, it does not need an FWA.

If it does want to apply for federal grant funds and signs an FWA, it has several options to consider. These are best understood in response to specific questions.

a. How extensive are the required assured protections? Every institution must agree to comply with Subpart A (the Common Rule). Subparts B (extra protections for pregnant women, fetuses & neonates), subpart C (extra protections for prisoners), and subpart D (extra protections for minors) are optional to adopt, but institutions accept or opted out of accepting them as a group. GVSU has opted put of the additional protections required in the subparts B, C and D.

b. Does the assurance cover studies that are not federally funded? GVSU is required to indicate on its FWA document whether its assurance applies to all research, or only to federally funded research. GVSU as extended its assurance to only those research projects that receive federal funding for the research.

c. Does the FWA expire? The FWA is renewed every 5 years but the choices about the extent of protection assurance may be amended at any time.

d. Who is accountable for the institution's assurances? Whomever signs the FWA on behalf of the institution is the accountable party if a complaint is received or a regulatory violation occurs. At GVSU the signatory official is the Research Integrity Officer (RIO).

e. Can the institution amend its FWA to get grant money? Yes, at any time. Some federal agencies and some private pharmaceutical companies require specific assurances to include one or more of the subparts B, C or D in order to be eligible to receive their grant money. This may require filing a protocol specific amendment to the FWA if the relevant subparts were not initially included. In addition, some federal agencies add additional rules to the regulations and require special amendments be signed to receive funding support for their projects. They also may require that additional training in participant protections be completed by the institutional official, chair of the HRRC, individual researchers, and possibly others. The US military does this and each branch has its own set of amendments and training requirements. An amendment to the FWA may only be made by the signatory official (RIO) or their designee.